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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650 Back to Search Results
Model Number KD-650L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Perforation (2001)
Event Date 02/10/2022
Event Type  Injury  
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. The literature article is attached for additional information. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Event Description
Olympus reviewed the literature titled "risk factors for lymph node metastasis and indication of local resection in duodenal neuroendocrine tumors". The present study aimed to investigate the clinicopathological features of duodenal neuroendocrine tumors (dnets) with a relatively large number of cases and identify the risk factors for lymph node metastasis (lnm). In addition, short- and long-term outcomes of endoscopic resection (er) and laparoscopy and endoscopy cooperative surgery (lecs) were compared to establish the application of local resection for dnets. 55 patients with 60 dnets were enrolled; dnets <5 mm were treated with er and those of 5¿10 mm were treated with lecs. Lnm was present in four (8. 7%) patients. No significant differences were observed in terms of complication rates. No recurrence was observed in any of the groups. Type of adverse events/number of patients: [endoscopic resection group (n
=
18)]. Intraoperative perforation- 2 patients. [lecs group (n
=
9)]. Abdominal abscess- 1 patient. The authors used 3 olympus devices and did not specify which device was involved with the adverse events: patient identifier (b)(6): gif-q260j. Patient identifier (b)(6): kd-611l. Patient identifier (b)(6): kd-650l. This report is 3 of 3 for patient identifier (b)(6): kd-650l.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-650
Type of DeviceSINGLE USE ELECTROSURGICAL KNIFE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key14602590
MDR Text Key293357392
Report Number8010047-2022-09478
Device Sequence Number1
Product Code KNS
UDI-Device Identifier04953170265761
UDI-Public04953170265761
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-650L
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/06/2022 Patient Sequence Number: 1
Treatment
SERIAL UNK: GIF-Q260J, ESG-100
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